The challenge of COVID-19 for a Clinical Microbiology Department.

OBJECTIVES: To quantify the workload and cost overload that the COVID-19 pandemic has meant for a Clinical Microbiology laboratory in a real-life scenario. METHODS: We compared the number of samples received, their distribution, the human resources, and the budget of a Microbiology laboratory in the COVID pandemic (March-December 2020) with the same months of the previous year. RESULTS: the total number of samples processed in the Clinical Microbiology laboratory in March to December 2020 increased 96.70% with respect to 2019 (from 246,060 to 483,993 samples), reflecting an increment of 127.50% when expressed as samples/1000 admissions (from 6057 to 13,780). The increase in workload was mainly at the expense of the virology (+2058%) and serology (+86%) areas. Despite additional personnel hiring, the samples processed per technician increased 12.5%. The extra cost attributed to Microbiology amounts to 6,616,511 euros (114.8%). CONCLUSIONS: This is the first study to provide quantitative figures about workload and cost increase caused by the COVID-19 in a Microbiology laboratory.

American Society for Clinical Pathology's 2019 Wage Survey of Medical Laboratories in the United States.

OBJECTIVES: To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. METHODS: The 2019 Wage Survey was conducted through collaboration of the American Society for Clinical Pathology (ASCP) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. RESULTS: Compared with 2017, results show an overall increase in salaries for most laboratory occupations surveyed except cytogenetic technologists, laboratory information systems personnel, and performance improvement or quality assurance personnel. Geographically, laboratory professionals from urban areas earned more than their rural counterparts. CONCLUSIONS: As retirement rates continue to increase, the field needs to intensify its efforts on recruiting the next generation of laboratory personnel. To do so, the report urged the field to highlight advocacy for better salaries for laboratory personnel at the local and national levels when developing recruitment and retention strategies.

Assessment of Specimen Pooling to Conserve SARS CoV-2 Testing Resources.

OBJECTIVES: To establish the optimal parameters for group testing of pooled specimens for the detection of SARS-CoV-2. METHODS: The most efficient pool size was determined to be five specimens using a web-based application. From this analysis, 25 experimental pools were created using 50 µL from one SARS-CoV-2 positive nasopharyngeal specimen mixed with 4 negative patient specimens (50 µL each) for a total volume of 250 µL. Viral RNA was subsequently extracted from each pool and tested using the CDC SARS-CoV-2 RT-PCR assay. Positive pools were consequently split into individual specimens and tested by extraction and PCR. This method was also tested on an unselected group of 60 nasopharyngeal specimens grouped into 12 pools. RESULTS: All 25 pools were positive with cycle threshold (Ct) values within 0 and 5.03 Ct of the original individual specimens. The analysis of 60 specimens determined that 2 pools were positive followed by identification of 2 individual specimens among the 60 tested. This testing was accomplished while using 22 extractions/PCR tests, a savings of 38 reactions. CONCLUSIONS: When the incidence rate of SARS-CoV-2 infection is 10% or less, group testing will result in the saving of reagents and personnel time with an overall increase in testing capability of at least 69%.

The economic efficiency of clinical laboratories in public hospitals: A case study in Iran.

INTRODUCTION: Clinical laboratories are identified as one of the most important and expensive units of the health system. Therefore, it is essential to pay attention to these units' cost efficiency. This study purpose was to evaluate the economic efficiency of hospitals' laboratory units affiliated to Urmia University of Medical Sciences (UMSU), in order to assess their performance. METHODS: This research was a descriptive-analytic study that was accomplished in 2017. The statistical population of the study included all of the hospitals' clinical laboratories affiliated to UMSU. Moreover, DEA method and Deap2.1 software were used to analyze data. In this study, technical and allocative efficiencies of the studied laboratory units were also calculated in addition to the determination of the economic efficiency of the laboratories. RESULTS: The average economic efficiency of clinical laboratories calculated by DEA in 2017 was 0.676. This value was lower than the allocative and technical efficiency scores, which indicates that these units could attain full efficiency by reducing their costs without having any effect on output values. Moreover, about 14 percent of the clinical laboratory units were economically efficient. In addition, it is noteworthy to state that, from total of university hospital laboratories, only three hospitals had no economic excess or deficiency values of inputs. CONCLUSION: Considering that 76% of laboratory units have not been economically efficient, it is necessary for the laboratory managers to consider optimum allocating of resources, with respect to the cost of laboratory equipment and inputs in order to increase their units' economic efficiency.

Payments From Pharmaceutical Companies to Authors Involved in the Valsartan Scandal in Japan.

Importance: Financial relationships between pharmaceutical companies and physicians can bias the conduct, findings, and reporting of clinical trials. In Japan, the valsartan scandal was a significant event: all 5 key articles on the valsartan clinical trials were retracted after the revelation of data falsification. Consequently, the Japan Pharmaceutical Manufacturers Association issued transparency guidelines, and pharmaceutical payments have been publicly disclosed since 2013. However, the distribution of payments from pharmaceutical companies among authors involved in the valsartan scandal after its revelation has not been studied to date. Objective: To identify the characteristics and distribution of payments from pharmaceutical companies to researchers involved in the valsartan scandal in Japan by using a comprehensive payment database. Design, Setting, and Participants: This retrospective cross-sectional study, conducted from January 1, 2016, through September 30, 2017, used information on payments from 78 pharmaceutical companies to 50 authors of 5 articles retracted after the valsartan scandal: the Kyoto Heart Study, Jikei Heart Study, SMART (Shiga Microalbuminuria Reduction Trial), VART (Valsartan Amlodipine Randomized Trial), and Nagoya Heart Study. Payments from companies to physicians were analyzed during the period from January 1, 2016, to September 30, 2017. Main Outcomes and Measures: The main outcomes were the amount and proportion of payments made by pharmaceutical companies to authors, and the forms of these payments. Results: Of 50 eligible authors, 30 (60%) received payments from pharmaceutical companies in 2016. The payments in the Japanese yen totaled ¥67.15 million (US $590 896) and the mean (SD) payment was more than ¥1.34 million (¥3.01 million) (US $11 817 [$27 292]). Five authors (10%) received more than ¥5 million (US $44 000) and 3 authors (6%) received more than ¥10 million (US $88 000). The total payments to the corresponding author of each article was ¥29 million (US $255 307), accounting for 43.2% of the total payments. Regarding forms of the payments, lecture fees accounted for 81.3% of the total payment (¥54.56 million). Conclusions and Relevance: Many authors involved in the valsartan scandal received payments from the pharmaceutical industry. Although whether such payments to these authors have decreased since the scandal is unclear, the findings appear to demonstrate that their financial relationships with the industry are still prominent. The findings of the study appear to support the need to encourage more transparency in such relationships because misconduct can occur within unclear relationships.

The American Society for Clinical Pathology's 2017 Wage Survey of Medical Laboratories in the United States.

Objectives: To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. Methods: The 2017 Wage Survey was conducted through collaboration between the American Society for Clinical Pathology's (ASCP's) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, IL. Results: Compared with 2015, results show an overall increase in salaries for most of the laboratory occupations surveyed except histotechnologists and pathologists' assistants. Geographically, laboratory professionals from urban areas earn more than their rural counterparts. Conclusions: Survey results encourage laboratory professionals to be actively engaged in advocating for the profession in the workforce and educational training programs. Awareness of the career opportunities and value of the profession is needed to strengthen the future of the field.

Laboratory Workflow Analysis of Culture of Periprosthetic Tissues in Blood Culture Bottles.

Culture of periprosthetic tissue specimens in blood culture bottles is more sensitive than conventional techniques, but the impact on laboratory workflow has yet to be addressed. Herein, we examined the impact of culture of periprosthetic tissues in blood culture bottles on laboratory workflow and cost. The workflow was process mapped, decision tree models were constructed using probabilities of positive and negative cultures drawn from our published study (T. N. Peel, B. L. Dylla, J. G. Hughes, D. T. Lynch, K. E. Greenwood-Quaintance, A. C. Cheng, J. N. Mandrekar, and R. Patel, mBio 7:e01776-15, 2016, https://doi.org/10.1128/mBio.01776-15), and the processing times and resource costs from the laboratory staff time viewpoint were used to compare periprosthetic tissues culture processes using conventional techniques with culture in blood culture bottles. Sensitivity analysis was performed using various rates of positive cultures. Annualized labor savings were estimated based on salary costs from the U.S. Labor Bureau for Laboratory staff. The model demonstrated a 60.1% reduction in mean total staff time with the adoption of tissue inoculation into blood culture bottles compared to conventional techniques (mean ± standard deviation, 30.7 ± 27.6 versus 77.0 ± 35.3 h per month, respectively; P < 0.001). The estimated annualized labor cost savings of culture using blood culture bottles was $10,876.83 (±$337.16). Sensitivity analysis was performed using various rates of culture positivity (5 to 50%). Culture in blood culture bottles was cost-effective, based on the estimated labor cost savings of $2,132.71 for each percent increase in test accuracy. In conclusion, culture of periprosthetic tissue in blood culture bottles is not only more accurate than but is also cost-saving compared to conventional culture methods.

Sustainable Development of Pathology in Sub-Saharan Africa: An Example From Ghana.

CONTEXT: - Pathology services are poorly developed in Sub-Saharan Africa. Komfo Anokye Teaching Hospital in Kumasi, Ghana, asked for help from the pathology department of the University Hospital of North Norway, Tromsø. OBJECTIVE: - To reestablish surgical pathology and cytology in an African pathology department in which these functions had ceased completely, and to develop the department into a self-supporting unit of good international standard and with the capacity to train new pathologists. DESIGN: - Medical technologists from Kumasi were trained in histotechnology in Norway, they were returned to Kumasi, and they produced histologic slides that were temporarily sent to Norway for diagnosis. Two Ghanaian doctors received pathology training for 4 years in Norway. Mutual visits by pathologists and technologists from the 2 hospitals were arranged for the introduction of immunohistochemistry and cytology. Pathologists from Norway visited Kumasi for 1 month each year during 2007-2010. Microscopes and immunohistochemistry equipment were provided from Norway. Other laboratory equipment and a new building were provided by the Ghanaian hospital. RESULTS: - The Ghanaian hospital had a surgical pathology service from the first project year. At 11 years after the start of the project, the services included autopsy, surgical pathology, cytopathology, frozen sections, and limited use of immunohistochemistry, and the department had 10 residents at different levels of training. CONCLUSIONS: - A Ghanaian pathology department that performed autopsies only was developed into a self-supported department with surgical pathology, cytology, immunohistochemistry, and frozen section service, with an active residency program and the capacity for further development that is independent from assistance abroad.

The American Society for Clinical Pathology's 2015 Wage Survey of Medical Laboratories in the United States.

OBJECTIVES: To inform the pathology and laboratory field of the most recent national wage data from the American Society for Clinical Pathology (ASCP). Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. METHODS: The 2015 wage survey was conducted through collaboration between the ASCP's Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Electronic survey invitations were sent to individuals who are currently practicing in the field. RESULTS: Data reveal increased salaries since 2013 for all staff-level laboratory professionals surveyed except phlebotomists and pathologists' assistants. Laboratory assistants and phlebotomists, regardless of level, continue to have lower salaries while pathologists' assistants and administration personnel have higher salaries than the rest of the laboratory professions surveyed. CONCLUSIONS: Survey results put emphasis on strategic recruitment and retention by laboratory training programs and institutions that hire laboratory professionals.

The American Society for Clinical Pathology's 2015 Wage Survey of Medical Laboratories in the United States.

OBJECTIVES: To inform the pathology and laboratory field of the most recent national wage data from the American Society for Clinical Pathology (ASCP). Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. METHODS: The 2015 wage survey was conducted through collaboration between the ASCP's Institute of Science, Technology, & Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Electronic survey invitations were sent to individuals who are currently practicing in the field. RESULTS: Data reveal increased salaries since 2013 for all staff-level laboratory professionals surveyed except phlebotomists and pathologists' assistants. Laboratory assistants and phlebotomists, regardless of level, continue to have lower salaries while pathologists' assistants and administration personnel have higher salaries than the rest of the laboratory professions surveyed. CONCLUSIONS: Survey results put emphasis on strategic recruitment and retention by laboratory training programs and institutions that hire laboratory professionals.

Erythrocytapheresis compared with whole blood phlebotomy for the treatment of hereditary haemochromatosis.

BACKGROUND: Hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy. We studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis. MATERIALS AND METHODS: In a prospective, randomised, open-label study, patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy. Primary end-points were decrease in ferritin levels and transferrin saturation. Secondary endpoints were decrease in haemoglobin levels, discomfort during the therapeutic procedure, costs and technicians' working time. RESULTS: Sixty-two patients were included. Thirty patients were randomised to apheresis and 32 to whole blood phlebotomy. Initially, ferritin levels declined more rapidly in the apheresis group, and the difference became statistically highly significant at 11 weeks; however, time to normalisation of ferritin level was equal in the two groups. We observed no significant differences in decline of transferrin saturation, haemoglobin levels or discomfort. The mean cumulative technician time consumption until the ferritin level reached 50 µg/L was longer in the apheresis group, but the difference was not statistically significant. The cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group. CONCLUSION: Treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient, but not in earlier achievement of target ferritin level. The frequency of discomfort was equally low with the two methods. The costs and, probably, technician time consumption were higher in the apheresis group.

Rapid on-site assessment of specimens by biomedical scientists improves the quality of head and neck fine needle aspiration cytology.

OBJECTIVE: Immediate rapid on-site assessment (ROSA) of fine needle aspiration cytology (FNAC) specimens by biomedical scientists (BMS), the UK equivalent of cytotechnologists, or by pathologists may improve specimen quality and cellular adequacy rates for lymph node, head and neck and thyroid FNAC. The aim of this study was to evaluate the effect of introducing ROSA by BMS in an outpatient clinic setting. METHODS: The adequacy rate and sensitivity of histological diagnosis for lymph node, thyroid and salivary gland FNAC samples were determined before and after the introduction of BMS ROSA. The additional financial costs and time required to perform this service were also estimated. RESULTS: Thirty-one patients underwent ultrasound (US)-guided FNAC with ROSA and 151 without. ROSA reduced the number of FNAC insufficient in quality for diagnosis from 43% to 19% (P = 0.0194). The estimated additional cost for pathology per patient for ROSA was between £52.05 and £70.74, equivalent to €65.40/US $83.90 and €88.89/US $114.0, respectively, an increase of between 28% and 49% from the original cost. ROSA necessitated an additional 6 minutes clinic time per patient, reducing the number of patients that could be seen in an average clinic from 13 to 10 as well as requiring increased laboratory time for FNAC slide assessment. CONCLUSION: ROSA by suitably trained biomedical scientists and with appropriate consultant pathologist support can improve the quality of FNAC sampling for head and neck lesions. Although ROSA resulted in both additional financial and time costs, these are more than likely to be offset by a reduction in patients returning to clinic for repeat FNAC or undergoing unnecessary surgery.